The following data is part of a premarket notification filed by Mcneil Healthcare, Inc. with the FDA for Neurological Sponges.
| Device ID | K935883 |
| 510k Number | K935883 |
| Device Name: | NEUROLOGICAL SPONGES |
| Classification | Gauze/sponge, Internal, X-ray Detectable |
| Applicant | MCNEIL HEALTHCARE, INC. P.O. BOX 964 Waterford, CT 06385 |
| Contact | Timothy D Mcneil |
| Correspondent | Timothy D Mcneil MCNEIL HEALTHCARE, INC. P.O. BOX 964 Waterford, CT 06385 |
| Product Code | GDY |
| CFR Regulation Number | 878.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-09 |
| Decision Date | 1994-02-03 |